Symmetry Surgical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Symmetry Surgical, Inc.” (first 2013, latest 2018), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 157 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 157 |
| 2014 | 0 | — |
| 2015 | 1 | 199 |
| 2016 | 2 | 168 |
| 2017 | 0 | — |
| 2018 | 1 | 120 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Symmetry Surgical, Inc. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAE | Rongeur, Manual | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
Most recent Symmetry Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173272 | Ergonomic Handle | GCJ | 2018-02-09 | 120 |
| K161744 | Symmetry Sharp Kerrison Rongeur | HAE | 2016-09-07 | 75 |
| K152111 | Symmetry Surgical Quad-Lock Container System | KCT | 2016-04-14 | 260 |
| K143078 | Bookwalter Gordon Adjustable Compression Element | DXC | 2015-05-14 | 199 |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | HAE | 2013-08-05 | 157 |
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-11-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Symmetry Medical (3 510(k)s)
- Symmetry Medical Inc- Manchester (1 510(k)s)
- Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. (1 510(k)s)
- Symmetry Medical USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Symmetry Surgical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Symmetry Surgical, Inc.” (first 2013, latest 2018), across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Symmetry Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Symmetry Surgical, Inc. is 157 days.
Which FDA product codes appear under Symmetry Surgical, Inc.?
The most frequent FDA product codes under this applicant name are HAE (Rongeur, Manual, 2); DXC (Clamp, Vascular, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 5 Symmetry Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAE, Symmetry Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.